Scandinavian Regulatory Services, SRS, provides expert regulatory and quality support to bring new and established medical devices, generic and established pharmaceuticals, and combination products to the market. Our specialty is in market access through regulatory approvals as well as compliance activities in the post-approval phase.
With a team of dedicated experts in all aspects of regulatory affairs and quality systems, we offer flexible solutions tailored for our clients. Our consultants have long-term experience in their respective areas. SRS provides expertise throughout EU/EEA and in collaboration with our partners, within areas such as USA, China and Latin America.
SRS is responsible for market access for the Nordic countries within the international network PharmaPriceInternational, PPI. Through the PPI network we have access to pricing and reimbursement experts in the major geographies of the world.
Within pharmaceuticals, we offer a broad range of Regulatory Affairs and Quality Assurance services including Marketing Authorisation Holder/Registration, local pharmacovigilance, Due Diligence and Market Access services.
We provide tailored solutions for companies independent of size. Whether it is to act as the Regulatory Affairs function or to support an existing Regulatory Affairs teams. We support with everything from initial Marketing Authorization Application to Life Cycle Management Post-marketing life cycle management of regulatory files to remain compliant with current regulations and maintained in the best way, eg. variations, renewals, conversion of old dossier documents to CTD format etc. of approved products.
Examples of regulatory services
- Product registration Compilation of registration dossiers and management of marketing authorization applications in national and small and large MRP/DCP procedures.
- Life Cycle Management Post-marketing life cycle management of regulatory files to remain compliant with current regulations and maintained in the best way, eg. variations, renewals, conversion of old dossier documents to CTD format etc.
- eCTD submission Regulatory Submissions in the electronic (eCTD) format to the Health Authorities
- Nordic Regulatory Affairs Office Taking full responsibility for all regulatory Affairs work in the Nordic countries, from initial MA application to regulatory launch activities and local pharmacovigilance (PV).
- MAH sevices MAH (marketing authorization holder) solution to enable submission while you acquire the necessary permits and establish your quality system.
- Regulatory Strategies Expertise in international regulatory affairs and understanding of the requirements in the EU, ensures that we can help you develop and optimize your regulatory strategy for generic, hybrid and well-established medicinal products.
- Authority interactions
- Due Diligence of product dossiers
- Translations of Product Information
- Review and approval of promotional material
- Catalogue texts for all Nordic countries
We provide tailored solutions for companies independent of size. Whether it is to act as a small company’s full QA/local PV function, establish a new quality system or to provide support to an existing quality existing organization.
SRS offers experienced QA support within the areas of good distribution practices (GDP) and good manufacturing practices (GMP); including RP/QP and local PV services.
Examples of Quality/PV services
- Quality Management System setup and maintenance
- Wholesale distribution and authorization – GDP Taking full responsibility for a company’s quality work related to WD licensing and maintaining the license.
- Temporary/interim QA support
- Audits Our experienced consultants are trained auditors for internal as well as supplier audits. Joint audits of contractors used by many of our customers are arranged regularly.
- Health authority inspection preparation and support
- Qualified Person (GMP) / Responsible Person (GDP)
- Local Complaints management
- Local pharmacovigilance office
- Medical Information
We provide support from device development stage and throughout the life cycle of your medical device/In-vitro device (IVD). Whether it is quality, regulatory or product development expertise you require, SRS provides competent support.
SRS offers experienced support to establish and maintain your quality system in accordance with ISO 13485 and US 21 CFR 820. This includes the expertise of performing internal and supplier audits Our experienced consultants are trained auditors for internal as well as supplier audits. Joint audits of contractors used by many of our customers are arranged regularly. and to manage Q and RA strategies and work in product development. Our experienced consultants provides support in strategic discussions as well hands on work in the steps needed to meet the European MDR/IVDR requirements. Risk management files, registration of medical devices and IVDs both in Europe (CE certification) and other markets worldwide, gap-analysis, due diligences and more.
Examples of services
- Building and updating quality systems according to ISO 13485 and US 21 CFR 820
- QA/RA Support and strategies
- Product classification and possible routes to CE-marking
- Establishment and maintenance of CE certification and technical dossier MDR / IVDR – MDD / IVDD
- Gap- analysis
- Product development Q&RA and/or modification strategies
- Agency/Notified Body interactions
- Post Market activities such as PSUR and PMCF
- International registrations incl US FDA
- Internal and supplier audits Our experienced consultants are trained auditors for internal as well as supplier audits. Joint audits of contractors used by many of our customers are arranged regularly.
- Implementation of the MDSAP program
- Interim QA and RA Manager
- PRRC role and EU Authorized Representative
- Due Diligence
With long experience from regulatory affairs and quality, in both medical device and pharmaceutical industries, SRS provides competent support to companies with drug/device combination products. Solutions are individually tailored to the needs.
With the introduction of the new European medical device legislation, EU MDR, the requirements for integral combination products have increased. The combined benefits of the products must be documented, and the quality system adapted to cover the full combination. The approval of these combination products now involves not only the medicinal products authority but, in many cases, also the Notified Body, or vice versa.
Examples of services
- Strategies and legal determinations:
- Drug with device component or
- Device incorporating a drug.
- Regulatory Support establishing Technical Documentation and Marketing Authorization application (MAA) as required
- Regulatory support establishing combination product documentation for US FDA
- Quality Assurance Support; establishing the QMS for the combination
- Notified body and competent authority interactions
- Release, responsible persons (QP, PRRC)
- Post market activities
Cosmetics and Food supplement
In the areas of food supplements and cosmetics, we offer support with safety assessment, product information files, labeling and more.
Examples of cosmetic services
- Safety assessment and compilation of cosmetic safety reports – CPSR
- Prepare and quality assure the product information file (PIF)
- Review of ingredient lists
- Labelling of products
- Product notification in the European CPNP database
- Risk assessment and safety assessments of raw material and products
Examples of Nutrition and Food Supplement services
- Compliance with Swedish and Nordic legislation and industry guidelines
- Authority and stakeholder interaction
- Contact with manufacturers
- Labeling compliance
- Nutrition and health claim strategies
- Calculations: Nutritional value